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A Study to Investigate Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Pain Derived From Exposed Dentine in Response to Chemical, Thermal, Tactile, or Osmotic Stimuli. | Clinical Trials | Clareo Health

COMPLETEDNA

A Study to Investigate Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Pain Derived From Exposed Dentine in Response to Chemical, Thermal, Tactile, or Osmotic Stimuli.

A Clinical Study Investigating the Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Dentinal Hypersensitivity

NCT02651467•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This will be a single center, eight week, randomized, double blind, three treatment arm, parallel design, stratified (by mean baseline Schiff Sensitivity Score of the two selected test teeth) study in healthy participants.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
•Participants will be male or female aged between 18 and 65 years inclusive.
•Good general and mental health with, in the opinion of the investigator or medically qualified designee.
•No clinically significant and relevant abnormalities in medical history or upon oral examination.
•Absence of any condition that would impact on the participant's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
•Self-reported history of dentinal hypersensitivity (DH) lasting more than(\>) six months but not \> 10 years.
•Good general oral health, with a minimum of 20 natural teeth.
•Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants at screening and minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars) at baseline.

Exclusion Criteria

•Women who are pregnant or breast-feeding .
•Daily doses of medication/treatments which, in the opinion of the Investigator, could interfere with the perception of pain. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, anti-depressants, mood-altering and anti-inflammatory drugs.
•Currently taking antibiotics or has taken antibiotics within two weeks of Baseline.
•Daily dose of a medication which, in the opinion of the investigator, is causing xerostomia.
•Presence of kidney disease, hyperoxaluria, or any other condition that may be exacerbated by oxalic acid or oxalate salts.
•Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.
•Any condition which, in the opinion of the investigator, causes xerostomia.
•Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
•Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
•Previous participation in this study.
+11 more criteria

Locations (1)

GSK Investigational Site

Fort Wayne, Indiana, United States

Key Dates

Start Date

January 4, 2016

Primary Completion Date

April 1, 2016

Completion Date

April 22, 2016

Last Updated

August 27, 2018

Enrollment

221

ACTUAL participants

Conditions

Dentin Sensitivity

Interventions

Experimental Oral Rinse 1 (1.5% w/w KOX, 0ppm F, pH 7.0)

OTHER

Experimental Oral Rinse 2 (2.0% w/w KOX, 45ppm F, pH 4.5)

OTHER

Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )

OTHER

A Clinical Study to Evaluate the Effectiveness of an Test Toothpaste for the Relief of Dentin Hypersensitivity in a Chinese Population

NCT07352956

Dentin Sensitivity

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COMPLETEDNA

Clinical Evaluation of Polycation-based New Dental Desensitizer on Dentin Hypersensitivity

NCT06378255

Dentin Sensitivity

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COMPLETEDPHASE1/PHASE2

Evaluation of the Safety and Tolerability of KH001 in Dentin Hypersensitivity Patients

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 27, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study to Investigate Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Pain Derived From Exposed Dentine in Response to Chemical, Thermal, Tactile, or Osmotic Stimuli.

Inclusion Criteria

Exclusion Criteria

A Clinical Study to Evaluate the Effectiveness of an Test Toothpaste for the Relief of Dentin Hypersensitivity in a Chinese Population

Clinical Evaluation of Polycation-based New Dental Desensitizer on Dentin Hypersensitivity

Evaluation of the Safety and Tolerability of KH001 in Dentin Hypersensitivity Patients

Efficacy and Safety Assessment of Experimental Bleaching Agents

A Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste for the Relief of Dentine Hypersensitivity in a Chinese Population

Propolis in Reducing Dentin Hypersensitivity